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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceGELFOAM PLUS HEMOSTATIC KIT
Generic NameAgent, absorbable hemostatic, collagen based
Regulation Number878.4490
ApplicantPFIZER, INC.
235 EAST 42ND ST.
NEW YORK, NY 10017
PMA NumberN18286
Supplement NumberS017
Date Received05/24/2007
Decision Date12/13/2007
Product Code LMF 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A NEW KIT CONFIGURATION TO INCLUDE HUMAN THROMBIN. THE KIT IS TO BE PREPARED AT THE BAXTER HEALTHCARE CORPORATION PLANT IN HAYWARD, CALIFORNIA. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME GELFOAM PLUS HEMOSTASIS KIT AND IS INTENDED AS A HEMOSTATIC DEVICE FOR SURGICAL PROCEDURES WHEN CONTROL OF CAPILLARY, VENOUS, AND ARTERIOLAR BLEEDING BY PRESSURE, LIGATURE, AND OTHER CONVENTIONAL PROCEDURES IS EITHER INEFFECTIVE OR IMPRACTICAL.
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